Primary Function:

To support timely and high quality data review and query management of clinical data.

Major Responsibilities and Duties:

• Participate in DM activities including but not limit to DM status report generation, Data Listing generation, Lab normal range management, Query management, e-Data reconciliation, and Data manual review. 
• Assist with Data Manager for application of standards, data acquisition, proactive data review and query management, data cleaning, e-data processing, data access and visualization, DM metrics reporting, database release, and submission related activities
• Ensure work carried out in accordance with applicable SOPs and working practices.

Qualifications:

• Awareness of clinical development and pharmaceuticals as a regulated industry
• Awareness of healthcare regulatory authorities (e.g. NMPA, FDA)
• Ability to learn clinical data management processes and principles in area of responsibility.
• Demonstrates required verbal and written communication skills including ability to communicate remotely
• Capable to learn technical data systems
• Awareness of MedDRA/WHO-Drug preferred
• Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)
• Bachelor’s degree minimum requirement. Health Sciences experience or Technology degree preferred.
• Attendances requirement:  At least 3 days a week, last for more than 3 months is preferred.